BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TIBIAL POLY BEARING

    MDR report key: 21143564 · Received January 13, 2025

    Report

    Report Number
    0001825034-2025-00134
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    December 24, 2024
    Report Date
    June 19, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG # 178711 LOT # 073090. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4; B5; D4; D5; D9; G3; H2; H3; H4; H6; H10; H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF USE AND IMPLANTATION AS THE IMPLANT SHOWS WEAR AND IS FRACTURED. DIMENSIONAL ANALYSIS OF THE PRODUCT DETERMINED THAT THE PRODUCT, WHERE MEASURED, WAS CONFORMING TO PRINT SPECIFICATIONS. THE DEVICE WAS SUBMITTED FOR FURTHER ANALYSIS. ANALYSIS DETERMINED THE SUPERIOR SURFACE OF THE BEARING AND INFERIOR SURFACE SHOW EVIDENCE OF POSSIBLE DELAMINATION AND/OR OXIDATION, AND THE FRAGMENT SHOWS EVIDENCE OF POSSIBLE DELAMINATION AND/OR OXIDATION AS WELL. THE TIMELINE OF THE ITEM FRACTURES CANNOT BE STATED WITH CERTAINTY SINCE NO FURTHER DETAILS WERE PROVIDED, BUT IT IS SUSPECTED THAT OVERLOADING, ESPECIALLY AROUND THE POSTERIOR SIDE OF THE BEARING POTENTIALLY LED OVER TIME TO HIGH OXIDATION AND THE ASSOCIATED DELAMINATION, WHICH INCREASED THE BRITTLENESS AND DECREASED THE STRENGTH OF THE BEARING, LEADING TO INCREASED POTENTIAL OF A FRACTURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO BROKEN IMPLANT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897581 OSS TIBIAL POLY BEARING PROSTHESIS KNEE JDI ZIMMER BIOMET, INC. N/A 523810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.